Home / 510(k) Clearances / K250850

510(k) K250850

Nanox.ARC X by Nano-X Imaging , Ltd. — Product Code IZF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 2025
Date Received
March 20, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Tomographic
Device Class
Class II
Regulation Number
892.1740
Review Panel
RA
Submission Type

Other clearances by Nano-X Imaging , Ltd.

  • K252649 — TAP2D (February 2, 2026)
  • K242395 — Nanox.ARC (December 4, 2024)
  • K222934 — Nanox.ARC (April 28, 2023)
  • K203782 — Nanox Cart X-ray System (April 1, 2021)

Other clearances for product code IZF

  • K252649 — TAP2D (February 2, 2026)
  • K252133 — Adaptix Ortho350 (November 6, 2025)
  • K242395 — Nanox.ARC (December 4, 2024)
  • K222934 — Nanox.ARC (April 28, 2023)
  • K221949 — Ortho Device, ADAPTIX 3D Orthopedic Imaging System (January 26, 2023)
  • K213081 — CLISIS SYSTEMS, Discovery RF180 (October 26, 2021)
  • K193262 — DR 600 with Tomosynthesis (March 9, 2020)
  • K183275 — DR 800 with Tomosynthesis (February 1, 2019)
  • K132261 — DISCOVERY XR656 WITH VOLUMERAD (DIGITAL TOMOSYNTHESIS) (November 18, 2013)
  • K121499 — FUJIFILM TOMOSYNTHESIS OPTION FOR FDR ACSELERATE STATIONARY X-RAY SYSTEM (November 20, 2012)